Hand DermatosesPhase 3NCT00309621
Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
A Phase 3 study testing alitretinoin in people with Hand Dermatoses, run by Basilea Pharmaceutica at 33 sites in 3 countries.
Trial summary
Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hand Dermatoses
- What is being tested?
- alitretinoin
- How many people
- 250 participants
- Where
- 33 sitesin 3 countries
- Study dates
- Apr 2006to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids
Who cannot join
- female of childbearing potential, unless participating in a pregnancy prevention program
- psoriasis
- active major psychiatric condition
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
Germany17 sites
Study site
Berlin, 12353
Study site
Berlin, 13439
Study site
Cologne, 51143
Study site
Frankfurt, 60326
Study site
Hamburg, 20246
Study site
Hamburg, 20354
Study site
Hamburg, 22143
Abt. Klinische Sozialmedizin
Heidelberg, 69115
Study site
Ibbenbueren, 49477
Study site
Lübeck, 23558
Study site
Mönchengladbach, 41061
Study site
München, 81375
Study site
Münster, 48143
Study site
Osnabrück, 49078
Study site
Potsdam, 14482
Study site
Viersen, 41747
Study site
Wuppertal, 42275
Canada10 sites
Study site
Edmonton, Alberta, T6G2G3
Study site
Hawkesbury, Ontario, K6A1A1
Study site
London, Ontario, N6H1S9
Study site
Markham, Ontario, L3P1A8
Study site
Montreal, Quebec, H3X1V6
Study site
Oakville, Ontario, L6J7W5
Study site
Québec, G1J1X7
Study site
Sheerbroke, Quebec, J1H1Z1
Study site
Vancouver, British Columbia, V5O3Y1
Study site
Winnipeg, Manitoba, R3C1R4
Poland6 sites
Study site
Gdansk
Study site
Krakow, 31-462
Study site
Lublin
Study site
Opole, 45-372
Study site
Szcecin
Study site
Wroclaw
About this study
Official title: Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.
Read the detailed description
For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.
Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.
This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.
- Conditions
- Hand Dermatoses
- Being tested
- alitretinoin
- Keywords
- Hand Dermatoses,, hand dermatitis, hand eczema, chronic hand dermatitis, retinoid
- Medical subject headings
- Hand Dermatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alitretinoinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety:
Adverse Events
Safety Laboratory
Radiological investigations (bone density, x-ray)
Secondary outcomes (4)
Physicians Global Assessment
modified Total Lesion Symptom Score
Patients Global Assessment
Patient Defined Outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand DermatosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Diepgen, MD, Principal investigator, Univ. Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309621
- Sponsor's protocol ID
- BAP00626
- Status last verified
- May 2023
- First submitted
- 30 Mar 2006
- Last updated
- 10 May 2023
- Results posted
- No
Publications
Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.
PubMed 15611422Blome C, Maares J, Diepgen T, Jeffrustenbach S, Augustin M. Measurement of patient-relevant benefits in the treatment of chronic hand eczema--a novel approach. Contact Dermatitis. 2009 Jul;61(1):39-45. doi: 10.1111/j.1600-0536.2009.01536.x.
PubMed 19659963
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
- ClinicalTrials.gov ID
- NCT00309621
- Acronym / sponsor ID
- BAP00626
- Conditions
- Hand Dermatoses
- Keywords
- Hand Dermatoses,, hand dermatitis, hand eczema, chronic hand dermatitis, retinoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.
Detailed description
For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.
Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.
This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids
Key exclusion criteria (3 listed)
- female of childbearing potential, unless participating in a pregnancy prevention program
- psoriasis
- active major psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alitretinoin | Drug | – |
Primary outcome
Safety:
Adverse Events
Safety Laboratory
Radiological investigations (bone density, x-ray)
4 secondary outcomes
Physicians Global Assessment
modified Total Lesion Symptom Score
Patients Global Assessment
Patient Defined Outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 15611422Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.
- Derived from this study: PubMed 19659963Blome C, Maares J, Diepgen T, Jeffrustenbach S, Augustin M. Measurement of patient-relevant benefits in the treatment of chronic hand eczema--a novel approach. Contact Dermatitis. 2009 Jul;61(1):39-45. doi: 10.1111/j.1600-0536.2009.01536.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Diepgen, MD principal investigator
Univ. Heidelberg
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alitretinoin in people with Hand Dermatoses, run by Basilea Pharmaceutica at 33 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety:. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00309621, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.